The RadiForce MX270W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not for use for screening or diagnostic mammography.

Device Description

The RadiForce MX270W is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 2560 x 1440 pixels (3.7MP) with a pixel pitch of 0.233 mm.

Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including MX270W based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce MX270W.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the EIZO RadiForce MX270W monitor.

Note: The provided document is a 510(k) summary for a medical display monitor. As such, the "device" in question is the monitor itself, and the "acceptance criteria" relate to its technical performance for displaying medical images, not a diagnostic AI algorithm. Consequently, many of the requested data points related to AI models (like sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, standalone AI performance) are not applicable to this type of medical device submission.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (RadiForce MX270W)
Resolution/Matrix Size	Equivalent to or better than predicate device (1600x1200)	2560 x 1440 pixels (3.7MP)
Pixel Pitch/Size	Equivalent to or better than predicate device (0.270 x 0.270 mm)	0.233 x 0.233 mm
DICOM Calibrated Luminance	Equivalent to or better than predicate device (150 cd/m2)	170 cd/m2
Maximum Luminance	Equivalent to predicate device (300 cd/m2)	300 cd/m2
Backlight Technology	No adverse effects on image quality from new technology	LED backlight (no adverse effects recognized)
Tone Curve Conformance	DICOM GSDF compliance	DICOM GSDF compliant
Video Interface	Equivalent or improved digital interface technology	Digital interfaces (DVI, DisplayPort only)
QC Software	Same as predicate device (for maintenance)	RadiCS / RadiCS LE
Backlight Stability	Equipped with Backlight Sensor (BS)	Equipped with BS
Grayscale Calibration	Accurate automatic or external calibration	Built-in Front Sensor (IFS) for automatic calibration, comparable accuracy to external sensors advertised.
DICOM GSDF Conformance	Conforms to AAPM TG18 guideline	Verification of conformance
Luminance Non-uniformity	Meets TG18 guideline specifications	Measurement taken, implicitly meets criteria
Chromaticity Non-uniformity	Meets TG18 guideline specifications	Measurement taken, implicitly meets criteria
Chromaticity at Center	Meets FDA guidance for FFDMM systems	Measurement taken, implicitly meets criteria
Artifact Presence	Absence of miscellaneous artifacts	Visual check of presence/absence
Pixel Defects/Faults	Within manufacturer's agreed limits	Meets agreed maximum numbers

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of an AI algorithm's test set. The "test set" here refers to individual monitors or a representative sample of monitors undergoing a series of bench tests. The document does not specify the number of monitors tested, but it implies standard manufacturing quality assurance and testing procedures.
Data Provenance: The tests were conducted by the manufacturer, EIZO NANAO Corporation, in Japan, prior to the 510(k) submission. This is retrospective data from internal testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission is for a display monitor, not an AI diagnostic algorithm. Ground truth, in the context of AI, usually refers to definitive diagnoses by experts or pathology. For a monitor, the "ground truth" and acceptance criteria are based on established technical standards and guidelines (like DICOM GSDF, AAPM TG18, FDA guidance for FFDMM systems) that define acceptable display performance. No individual medical expert "established" ground truth in this context; instead, the criteria are defined by industry and regulatory bodies.

4. Adjudication Method for the Test Set

Not applicable. Since there's no "ground truth" in the AI sense established by multiple experts requiring adjudication, there is no adjudication method used. The tests are quantitative and objective measurements against predefined technical specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI algorithms on human reader performance in diagnostic tasks. This submission is for a display monitor, which is a tool for viewing images, not an AI algorithm that assists in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone AI algorithm performance study was not done. This device is a monitor, not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Technical Standards and Guidelines: The "ground truth" for evaluating the RadiForce MX270W's performance is adherence to established technical specifications and industry standards for medical displays. These include:
- DICOM GSDF (Digital Imaging and Communications in Medicine Grayscale Standard Display Function)
- AAPM Task Group 18 (TG18) guidelines for "Assessment of Display Performance for Medical Imaging Systems"
- FDA Guidance for Industry and FDA Staff: "Display Accessories for Full-Field Digital Mammography Systems - Premarket Notification (510(k)) Submissions" (specifically for chromaticity measurement).
- Manufacturer's internal specifications and agreements with LCD panel suppliers for pixel defects.

8. The Sample Size for the Training Set

Not applicable. This device is a monitor, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set for an AI algorithm is involved.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for EIZO. The logo consists of a stylized, geometric shape above the company name. The shape is composed of a combination of solid black areas and a checkered pattern, giving it a three-dimensional appearance. The company name "EIZO" is printed in a bold, sans-serif font below the shape.

APR 2 0 2012

EIZO NANAO CORPORATION, 153 Shimokashiwano, Hakusan, Ishikawa924-8566 Japan	Name	Hiroaki Hashimoto
U.S. Food and Drug Administration	Department	Medical Device Standard
Center for Devices and Radiological Health
Document Mail Center - WO66-G609	Telephone	+81 (76) 274-2468
10903 New Hampshire Avenue	Fax	+81 (76) 274-2484
Silver Spring, MD 20993-0002	E-Mail	hiro@nanao.co.jp
	Date	October 25th, 2011

Traditional 510(k) Summary (in accordance with 21 CFR 807,92)

1. Date of Summary
  October 25th, 2011
1. Company EIZO NANAO CORPORATION 153 Shimokashiwano, Hakusan Ishikawa 924-8566 Japan
1. Authorized Contact Person Hiroaki Hashimoto

4. Device Information

. Trade Name/Model: RadiForce MX270W
. Common Name: 3.7MP Color LCD Monitor
Classification Name: . System, Image Processing, Radiological
Regulation Number: . 21 CFR 892.2050, Product Code LLZ

5. Predicate Device

Color LCD Monitor, RadiForce RS210 (K092613) .

6. Device Description

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7. Intended Use

The RadiForce MX270W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

8. Technological Characteristics

The RadiForce MX270W can be said to have at least the same display performances as those of the predicate device by default due to the following reasons:

Both the matrix size and the active area size of the LCD panel used (2,560 x 1,440, a. 596.7 mm x 335.6 mm) are larger than those of the predicate device (1,600 x 1,200, 432.0 mm x 324.0 mm).
The smaller pixel pitch or pixel size (0.233 x 0.233 mm) than that of the predicate b. device (0.270 x 0.270 mm) means higher density usually resulting in higher quality of displayed images. If one cares about the smaller pixel size, the perceived pixel size similar to that of the predicate device can be realized easily by adjusting the viewing distance.
The DICOM calibrated luminance (170 cd/m2) is higher than that of the predicate C. device (150 cd/m2) though the typical maximum luminance values of the both devices are the same (300 cd/m2). The higher calibrated luminance to be maintained constantly was realized by the employment of LED backlight deteriorating more slowly than conventional CCFL backlights.
The LED backlight was newly employed instead of CCFL backlight because it is d. mercury-free, consumes less power and deteriorates more slowly. We have not recognized any adverse effects of the LED backlight on the quality of displayed images. Refer to section 18 "Performance Testing - Bench" where several image quality characteristics of the proposed device are compared with those of the predicate device.
The both devices display images in accordance with DICOM GSDF by default e. utilizing the factory calibrated display mode stored in lookup tables inside of them.
Analog video interface is not supported by the proposed device. The quality of f. displayed images is usually better via digital interfaces like DVI or DisplayPort than via analog ones.

As for the maintenance, the same QC software is used for the both devices and the implementation of the Backlight Sensor (BS) stabilizing the backlight is also the same.

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As for built-in sensors, in addition to BS common to the both devices, MX270W has a Built-in Front Sensor (IFS). The IFS enables automatic grayscale calibration by measuring the luminance at the screen surface. Without IFS, the grayscale calibration process requires human intervention and the use of an external sensor. The accuracy data of the calibration with external sensors and that with the IFS is included in section 16.9 "Verification and Validation Documentation".

9. Performance Testing

The following bench tests were performed on the RadiForce MX270W :

. Verification of the conformance to DICOM GSDF as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)
. Measurement of the luminance non-uniformity characteristics of the display screen as specified in the TG18 guideline
Measurement of the chromaticity non-uniformity characteristics of the display screen as . specified in the TG18 guideline
. Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance as specified in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions
. Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in the TG18 guideline
. The maximum number allowed for each type of pixel defects/faults agreed with the manufacturer from which Eizo buys the LCD panels for RadiForce MX270W

The test results showed that the RadiForce MX270W has display performances substantially equivalence to those of the predicate device, RadiForce RS210. Besides, the display performances of the RadiForce MX270W meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce MX270W.

10.Conclusion

The 3.7MP color LCD monitor, RadiForce MX270W is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The specifications of the primary component employed by the proposed device are superior to those of the predicate device and other differences have been independently validated. Any differences between the devices do not affect safety or effectiveness.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-00002

Mr. Hiroaki Hashimoto Manager EIZO NANAO Corporation 153 Shimokashiwano HAKUSAN ISHIKAWA 924-8566 JAPAN

APR 2 0 2012

Re: K113240

Trade/Device Name: 3.7MP Color LCD Monitor, RadiForce MX270W Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 12, 2012 Received: April 17. 2012

Dear Mr. Hashimoto:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that I Drimes and regulations administered by other Federal agencies. You must or uny I out all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known):

3.7MP Color LCD Monitor, RadiForce MX270W Device Name:

Indications for Use:

X Over-The-Counter Use Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Pastel

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113240

Page 1 of 1

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).